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Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab

2018年7月10日更新者：UCB Pharma

Phase IIIb Open-label Induction and Double-blind Comparison of 2 Maintenance Schedules Evaluating Clinical Benefit and Tolerability of Certolizumab Pegol in Crohn's Disease Patients With Prior Loss of Response or Intolerance to Infliximab

To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over 26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with infliximab

研究概览

地位

完全的

条件

克罗恩病

干预/治疗

研究类型

介入性

注册 (实际的)

539

阶段

第三阶段

扩展访问

可用的查看扩展访问记录。

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

丹麦
- - Aalborg、丹麦
  - Arhus、丹麦
  - Copenhagen、丹麦
  - Herlev、丹麦
加拿大
- - Calgary、加拿大
- Alberta
  - Edmonton、Alberta、加拿大
- British Columbia
  - Vancouver、British Columbia、加拿大
- Ontario
  - London、Ontario、加拿大
  - Richmond、Ontario、加拿大
  - Toronto、Ontario、加拿大
奥地利
- - Innsbruck、奥地利
  - Oberpullendorf、奥地利
  - Wien、奥地利
德国
- - Berlin、德国
  - Hamburg、德国
  - Hannover、德国
  - Herne、德国
  - Kiel、德国
  - Leipzig、德国
  - Minden、德国
  - Munchen、德国
  - Munich、德国
意大利
- - Bari、意大利
  - Bologna、意大利
  - Milano、意大利
  - Padova、意大利
  - Palermo、意大利
  - Roma、意大利
  - Torino、意大利
挪威
- - Oslo、挪威
  - Tromso、挪威
比利时
- - Bonheiden、比利时
  - Brussels、比利时
  - Genk、比利时
  - Gent、比利时
  - Kortrijk、比利时
  - Leuven、比利时
  - Liege、比利时
  - Roeselare、比利时
法国
- - Amiens、法国
  - Clichy、法国
  - Grenoble, Cedex 9、法国
  - Lille、法国
  - Montpellier, Cédex 5、法国
  - Nice、法国、Cedex 3
  - Paris、法国
  - Pessac、法国
  - Rouen、法国
  - Toulouse, Cedex 9、法国
瑞典
- - Goteborg、瑞典
  - Malmo、瑞典
  - Orebro、瑞典
  - Stockholm、瑞典
瑞士
- - Basel、瑞士
  - Bern、瑞士
  - Lausanne、瑞士
美国
- California
  - San Francisco、California、美国
- Florida
  - Gainesville、Florida、美国
- Georgia
  - Atlanta、Georgia、美国
- Illinois
  - Chicago、Illinois、美国
- Indiana
  - Indianapolis、Indiana、美国
- Kentucky
  - Lexington、Kentucky、美国
  - Louisville、Kentucky、美国
- Louisiana
  - Baton Rouge、Louisiana、美国
- Maryland
  - Baltimore、Maryland、美国
- Massachusetts
  - Boston、Massachusetts、美国
- Minnesota
  - Rochester、Minnesota、美国
- Nebraska
  - Lincoln、Nebraska、美国
- New York
  - Great Neck、New York、美国
  - New York、New York、美国
- North Carolina
  - Chapel Hill、North Carolina、美国
  - Charlotte、North Carolina、美国
- Ohio
  - Cincinnati、Ohio、美国
  - Cleveland、Ohio、美国
- Oklahoma
  - Oklahoma City、Oklahoma、美国
- Oregon
  - Portland、Oregon、美国
- Pennsylvania
  - Philadelphia、Pennsylvania、美国
  - Pittsburgh、Pennsylvania、美国
- South Carolina
  - Charleston、South Carolina、美国
- Tennessee
  - Germantown、Tennessee、美国
  - Kingsport、Tennessee、美国
  - Nashville、Tennessee、美国
- Texas
  - Dallas、Texas、美国
  - Galveston、Texas、美国
  - Houston、Texas、美国
- Washington
  - Seattle、Washington、美国
- Wisconsin
  - Milwaukee、Wisconsin、美国
英国
- - Bristol、英国
  - Cambridge、英国
  - Edinburgh、英国
  - London、英国
  - Nottingham、英国
  - Oxford、英国
  - Sheffield、英国
荷兰
- - Amsterdam、荷兰
  - Eindhoven、荷兰
  - Enschede、荷兰
  - Heerlen、荷兰
  - Leiden、荷兰
  - Terneuven、荷兰
  - Zwolle、荷兰
西班牙
- - Barcelona、西班牙
  - Madrid、西班牙
  - Oviedo、西班牙
  - Santiago De Compostela、西班牙
  - Sevilla、西班牙
  - Valencia、西班牙

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Subjects with Crohn's Disease
Previous treatment failure to Infliximab (intolerance and/or no response)

Exclusion Criteria:

Obstructive intestinal strictures
Recent bowel resection
Proctocolectomy or total colectomy
Current total parenteral nutrition
Short bowel syndrome
All concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient
Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：双倍的

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Active 1 Q4W regimen - every 4 weeks: alternatively placebo and 400mg Certolizumab Pegol	生物：Certolizumab pegol 400mg Certolizumab Pegol, Q4W, administered 4-weekly 其他名称：西姆齐亚 CDP870 生物：Certolizumab pegol 400mg Certolizumab Pegol, Q2W, administered 2-weekly 其他名称：西姆齐亚 CDP870 其他：Placebo placebo administered 4-weekly in Active 1
实验性的：Active 2 Q2W regimen - every 2 weeks: 400 mg Certolizumab Pegol	生物：Certolizumab pegol 400mg Certolizumab Pegol, Q4W, administered 4-weekly 其他名称：西姆齐亚 CDP870 生物：Certolizumab pegol 400mg Certolizumab Pegol, Q2W, administered 2-weekly 其他名称：西姆齐亚 CDP870

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase 大体时间：Baseline to Week 6	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score) from baseline, otherwise there is a non-response. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 6

次要结果测量

结果测量	措施说明	大体时间
Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase 大体时间：Baseline to Week 26	Response is defined as at least 100 point decrease in CDAI score from baseline. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 26
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase 大体时间：Baseline to Week 6	Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 6
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase 大体时间：Baseline to Week 26	Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 26
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase 大体时间：Week 6	Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 6
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase 大体时间：Week 26	Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 26
CDAI Score at Week 2 of the Induction Phase 大体时间：Week 2	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 2
CDAI Score at Week 4 of the Induction Phase 大体时间：Week 4	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 4
CDAI Score at Week 6 of the Induction Phase 大体时间：Week 6	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 6
CDAI Score at Week 8 in the Randomized Maintenance Phase 大体时间：Week 8	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 8
CDAI Score at Week 10 in the Randomized Maintenance Phase 大体时间：Week 10	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 10
CDAI Score at Week 12 in the Randomized Maintenance Phase 大体时间：Week 12	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 12
CDAI Score at Week 14 in the Randomized Maintenance Phase 大体时间：Week 14	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 14
CDAI Score at Week 16 in the Randomized Maintenance Phase 大体时间：Week 16	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 16
CDAI Score at Week 18 in the Randomized Maintenance Phase 大体时间：Week 18	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 18
CDAI Score at Week 20 in the Randomized Maintenance Phase 大体时间：Week 20	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 20
CDAI Score at Week 22 in the Randomized Maintenance Phase 大体时间：Week 22	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 22
CDAI Score at Week 24 in the Randomized Maintenance Phase 大体时间：Week 24	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 24
CDAI Score at Week 26 in the Randomized Maintenance Phase 大体时间：Week 26	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 26
Change From Baseline in CDAI Score at Week 2 of the Induction Phase 大体时间：Baseline to Week 2	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 2
Change From Baseline in CDAI Score at Week 4 of the Induction Phase 大体时间：Baseline to Week 4	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 4
Change From Baseline in CDAI Score at Week 6 of the Induction Phase 大体时间：Baseline to Week 6	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 6
Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase 大体时间：Baseline to Week 8	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 8
Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase 大体时间：Baseline to Week 10	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 10
Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase 大体时间：Baseline to Week 12	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 12
Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase 大体时间：Baseline to Week 14	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 14
Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase 大体时间：Baseline to Week 16	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 16
Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase 大体时间：Baseline to Week 18	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 18
Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase 大体时间：Baseline to Week 20	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 20
Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase 大体时间：Baseline to Week 22	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 22
Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase 大体时间：Baseline to Week 24	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 24
Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase 大体时间：Baseline to Week 26	The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.	Baseline to Week 26
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. 大体时间：Week 10	Remission is defined as CDAI score ≤ 150.	Week 10
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. 大体时间：Week 12	Remission is defined as CDAI score ≤ 150.	Week 12
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. 大体时间：Week 14	Remission is defined as CDAI score ≤ 150.	Week 14
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. 大体时间：Week 16	Remission is defined as CDAI score ≤ 150.	Week 16
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. 大体时间：Week 18	Remission is defined as CDAI score ≤ 150.	Week 18
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. 大体时间：Week 20	Remission is defined as CDAI score ≤ 150.	Week 20
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. 大体时间：Week 22	Remission is defined as CDAI score ≤ 150.	Week 22
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. 大体时间：Week 24	Remission is defined as CDAI score ≤ 150.	Week 24
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. 大体时间：Week 26	Remission is defined as CDAI score ≤ 150.	Week 26
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. 大体时间：Week 10	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 10
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. 大体时间：Week 12	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 12
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. 大体时间：Week 14	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 14
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. 大体时间：Week 16	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 16
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. 大体时间：Week 18	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 18
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. 大体时间：Week 20	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 20
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. 大体时间：Week 22	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 22
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. 大体时间：Week 24	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 24
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. 大体时间：Week 26	Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).	Week 26
C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase 大体时间：Week 0	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 0
CRP Level at Week 2 of the Induction Phase 大体时间：Week 2	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 2
CRP Level at Week 4 of the Induction Phase 大体时间：Week 4	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 4
CRP Level at Week 6 of the Induction Phase 大体时间：Week 6	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 6
CRP Level at Week 8 in the Randomized Maintenance Phase 大体时间：Week 8	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 8
CRP Level at Week 10 in the Randomized Maintenance Phase 大体时间：Week 10 (optional measurement)	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 10 (optional measurement)
CRP Level at Week 12 in the Randomized Maintenance Phase 大体时间：Week 12	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 12
CRP Level at Week 14 in the Randomized Maintenance Phase 大体时间：Week 14 (optional measurement)	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 14 (optional measurement)
CRP Level at Week 16 in the Randomized Maintenance Phase 大体时间：Week 16	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 16
CRP Level at Week 18 in the Randomized Maintenance Phase 大体时间：Week 18 (optional measurement)	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 18 (optional measurement)
CRP Level at Week 20 in the Randomized Maintenance Phase 大体时间：Week 20	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 20
CRP Level at Week 22 in the Randomized Maintenance Phase 大体时间：Week 22 (optional measurement)	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 22 (optional measurement)
CRP Level at Week 24 in the Randomized Maintenance Phase 大体时间：Week 24	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 24
CRP Level at Week 26 in the Randomized Maintenance Phase 大体时间：Week 26	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.	Week 26
CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase 大体时间：Last visit on or before Week 26	High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. Endpoint is the visit when the last observation was taken, either at week 26 or at a visit before in case of early dropout.	Last visit on or before Week 26

其他结果措施

结果测量	措施说明	大体时间
Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6 大体时间：Week 6 to Week 26	Median time to loss of response in the maintenance period (from Kaplan-Meier analysis); range is time of first event to time of last event. Loss of response is defined as both a CDAI score > 150 points and a minimum increase in CDAI of 70 points versus Week 6 at two consecutive visits.	Week 6 to Week 26

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

UCB Pharma

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

FDA Safety Alerts and Recalls

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2006年4月1日

初级完成 (实际的)

2008年4月1日

研究完成 (实际的)

2008年4月1日

研究注册日期

首次提交

2006年3月28日

首先提交符合 QC 标准的

2006年3月28日

首次发布 (估计)

2006年3月29日

研究记录更新

最后更新发布 (实际的)

2018年8月7日

上次提交的符合 QC 标准的更新

2018年7月10日

最后验证

2011年4月1日

Certolizumab pegol的临床试验

UCB Pharma

完全的

Cimzia® 再治疗慢性斑块状银屑病患者的疗效

银屑病

法国, 德国
Michael Schiff, MD
UCB Pharma

完全的

TNF-Alpha 不完全二级反应者能否获得安全有效的反应切换到 Cimzia

类风湿关节炎

美国
Nathan Wei, MD, FACP, FACR:
University of California, San Diego

完全的

类风湿性关节炎治疗和活检研究评估 Certolizumab Pegol (Cimzia)

类风湿关节炎

美国
Novo Nordisk A/S

完全的

Turoctocog Alfa Pegol (N8-GP) 预防和治疗既往接受过治疗的中国 A 型血友病患者出血事件的疗效和安全性（探路者 10） (Pathfinder10)

血友病A

中国
Novo Nordisk A/S

招聘中

服用药物 Esperoct 对血友病患者关节健康的观察性研究

血友病A

加拿大
Bayer

主动，不招人

旨在了解更多关于接受 Damoctocog Alfa Pegol 治疗的 A 型血友病患者身体活动水平的研究（LIFE ACTIVE 研究） (LIFE-ACTIVE)

甲型血友病

加拿大, 西班牙, 美国, 比利时, 意大利, 台湾, 斯洛文尼亚
Novo Nordisk A/S

邀请报名

一项针对患有 A 型血友病的男性患者使用 Esperoct® 进行预防的研究 (pathfinder9)

血友病A

奥地利, 西班牙, 保加利亚, 克罗地亚, 爱沙尼亚, 匈牙利, 意大利, 立陶宛, 葡萄牙, 希腊, 德国, 捷克语, 斯洛文尼亚, 瑞士, 斯洛伐克
RenJi Hospital

尚未招聘

妊娠类风湿性关节炎的治疗

类风湿关节炎 | 怀孕相关

中国
Queen Mary University of London

完全的

评估 RA 患者对 TNFα 抑制剂的 Th17 反应 (THERAPIST)

类风湿关节炎

英国
IVERIC bio, Inc.

主动，不招人

地理萎缩患者的 Avacincaptad Pegol 开放标签扩展

黄斑变性 | 地理萎缩

美国, 拉脱维亚, 法国, 德国, 西班牙, 匈牙利, 加拿大, 以色列, 阿根廷, 捷克语, 哥伦比亚, 克罗地亚, 意大利

Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab

Phase IIIb Open-label Induction and Double-blind Comparison of 2 Maintenance Schedules Evaluating Clinical Benefit and Tolerability of Certolizumab Pegol in Crohn's Disease Patients With Prior Loss of Response or Intolerance to Infliximab

研究概览

地位

条件

干预/治疗

研究类型

注册 (实际的)

阶段

扩展访问

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

有资格学习的性别

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

其他结果措施

结果测量

措施说明

大体时间

合作者和调查者

赞助

出版物和有用的链接

一般刊物

有用的网址

研究记录日期

研究主要日期

学习开始

初级完成 (实际的)

研究完成 (实际的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (估计)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

Certolizumab pegol的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Estonia

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点